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510(k) Data Aggregation
(443 days)
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended.
The provided text describes a 510(k) premarket notification for the "GBR System" (K170697), a bone fixation system. The testing outlined assesses the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria for a new, standalone device's performance in a diagnostic or clinical efficacy context. Therefore, direct acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, AUC) and a study proving a device meets these in the way typically seen for AI/diagnostic devices are not applicable or present in this document.
However, I can extract the non-clinical performance testing conducted and its reported outcomes, which serve as the "acceptance criteria" for demonstrating substantial equivalence based on physical and biological properties.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Properties | Dimension Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device |
| Pull Out Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Torsion Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Tensile Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Bending Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Biocompatibility | ISO 10993-3, 10993-6, 10993-10, 10993-11 | Biocompatible | Test results and analysis found the device biocompatible |
| Sterilization | ISO 17665-1:2006 (for gravity displacement steam sterilization) | Sterility Assurance Level (SAL) of $10^{-6}$ | Demonstrated SAL of $10^{-6}$ |
| ISO 17665-1:2006 (for pre-vacuum steam sterilization) | Sterility Assurance Level (SAL) of $10^{-6}$ | Demonstrated SAL of $10^{-6}$ |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "bench testing" and "test results and analysis" but does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. The "acceptance criteria" here relate to physical, mechanical, and biological properties of the device, not a diagnostic or clinical performance where expert-established ground truth would be relevant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As above, adjudication methods apply to expert-based ground truth establishment, which is not relevant to the non-clinical bench and biocompatibility testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not mentioned and is not applicable to this type of device (bone fixation system) or the non-clinical testing described. This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical medical device, not an algorithm, and therefore "standalone" performance in this context is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" is defined by the standards and specifications outlined in the referenced ASTM and ISO standards. For example, for mechanical tests, the ground truth is the expected mechanical behavior according to the standard and comparison to the predicate device. For biocompatibility, it's compliance with ISO 10993 standards. For sterilization, it's achieving the specified SAL.
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical medical device and does not involve AI/machine learning, so there is no training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set for this type of device, this question is not relevant.
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